Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

Phase 3

Completed

• Conditions: Osteoporotic Vertebral Compression Fractures
• Interventions: Procedure: Kyphoplasty

• Registration Number: NCT00279877
• Lead Sponsor: University of Virginia

Brief Summary

Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vertebroplasty	Kyphoplasty	vertebroplasty
kyphoplasty	Kyphoplasty	kyphoplasty

Primary Outcome Measures

Name	Time	Method
Back specific functional status(Roland)	12 mo
Pain	12 mo

Secondary Outcome Measures

Name	Time	Method
Health status outcome measure(SF-36)	12 mo

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States